BENZOYL PEROXIDE  - benzoyl peroxide  gel 
MD Formulation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Benzoyl Peroxide 10&%

Benzoyl Peroxide 10%

Acne Treatment

Treats and helps prevent acne pimples.

Foe external use only

If swallowed, get medical help or contact a Poison Control Center right away.

Directions Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1 to 3 times dally. Because excessive drying of the skin may accur, start with 1 application daily, then gradually increase to 2 to 3 times daily If needed or as directed by a
physician. If bothersome dryness or peeling occurs, reduce application to once a day or every other other day.

Inactive Ingredients:
Water, glycerin, propylene glycol, carbomer, diazolidinyl urea, methylparaben, propylparaben, aminomethyl propanol.

Label
U Carton
BENZOYL PEROXIDE  
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66078-033-0254 in 1 CASE
11 in 1 CARTON
161.68 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/23/2001
Labeler - MD Formulation (087008363)
Registrant - Harmony Labs, inc. (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Harmony Labs, inc.105803274manufacture, label, pack, relabel, repack

Revised: 5/2011
Document Id: b558a27e-dcde-4ccd-a82c-d6c2a091a538
Set id: 4fc990de-ca8f-4d68-ad47-1f2b556f94b3
Version: 4
Effective Time: 20110518
 
MD Formulation